Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus

Chronic Hepatitis C Clinical Trial

Official title:

Open Label, Multiple-Dose Study to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of BMS-824393 in Treatment Naive Subjects Infected With Hepatitis C Virus Genotype 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971308
• Other study ID #: AI451-002
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2009
• Last updated: January 24, 2011
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: January 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the antiviral effect following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Treatment naive chronically infected subjects with Hepatitis C Virus genotype 1

• HCV RNA viral load of =10*5* IU/mL (100,000 IU/mL)

• Body Mass Index (BMI) of 18 to 35 kg/m², inclusive

Exclusion Criteria:

• Women who are pregnant or breast feeding

• Any significant acute or chronic medical illness which is not stable or is not controlled with medication or is not consistent with Hepatitis C infection

• Any other medical, psychiatric and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• BMS-824393
Capsule, Oral, 50mg, Once Daily, 3 days
• BMS-824393
Capsule, Oral, 100mg, Once Daily, 3 days
• BMS-824393
Capsule, Oral, 10mg, Once Daily, 3 days
• BMS-824393
Capsule. Oral, 1mg, Once Daily, 3 days
• BMS-824393
Capsule, Oral, Flexible, =100mg, Once Daily, 3 days

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Parexel International - Baltimore Epcu	Baltimore	Maryland
United States	West Coast Clinical Trials, Llc	Cypress	California
United States	Elite Research Institute	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Alamo Medical Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HCV RNA following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b HCV infected subjects		On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration	No
Secondary	To assess the change in HCV RNA over time during three days of dosing with BMS- 824393 and during the follow-up period in chronically genotype subtype 1a and 1b HCV infected subjects		On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration	Yes
Secondary	To assess potential differences in antiviral effect in genotype subtypes (1a versus 1b)		On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration	Yes
Secondary	To assess the safety and tolerability of multiple oral doses of BMS-824393		On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form